Core Insights - SS Innovations International, Inc. has successfully completed the world's first intercontinental robotic cardiac telesurgery, showcasing the capabilities of its SSi Mantra 3 surgical robotic system [1][4][6] Company Overview - SS Innovations is dedicated to making robotic surgery affordable and accessible globally, with a focus on innovative surgical robotic technologies [1][8] - The company has received regulatory approval from India's Central Drugs Standard Control Organization for both teleproctoring and telesurgery, distinguishing it from other surgical robotic companies [7] Surgical Achievements - The recent cardiac procedure involved a robotic atrial septal defect closure performed remotely from Strasbourg, France to Indore, India, covering a distance of over 4,000 miles [2][3] - To date, SS Innovations has completed 35 telesurgeries, including 10 cardiac procedures, demonstrating the effectiveness of the SSi Mantra system in complex surgeries [6] Technological Features - The SSi Mantra surgical robotic system includes advanced features such as modular robotic arms, a 3D 4K monitor, and the ability to superimpose 3D diagnostic imaging models, enhancing surgical precision and safety [12]

Core Viewpoint - SS Innovations International, Inc. successfully completed the world's first intercontinental robotic cardiac telesurgery, demonstrating the advanced capabilities of its SSi Mantra 3 surgical robotic system and paving the way for improved access to complex cardiac care globally [1][4]. Company Achievements - The cardiac procedure performed was a robotic atrial septal defect closure, conducted remotely from Strasbourg, France, to Indore, India, over a distance of more than 4,000 miles [2]. - A total of 35 telesurgeries, including 10 cardiac procedures, have been successfully completed using the SSi Mantra surgical robotic system, showcasing its effectiveness in complex surgeries [5]. - The SSi Mantra system has been clinically validated in over 100 different types of surgical procedures in India, with more than 5,000 multi-specialty surgeries performed without device-related adverse events [5][9]. Technological Innovation - The SSi Mantra surgical robotic system features a modular design with 3 to 5 robotic arms, a 3D 4K monitor, and advanced imaging capabilities, enhancing the safety and efficiency of surgical procedures [9]. - The system's telesurgery capabilities address traditional barriers related to travel, time, cost, and surgical accessibility, aiming to create a more equitable medical standard [4]. Regulatory Approval - SS Innovations is the only surgical robotic company to receive regulatory approval from India's Central Drugs Standard Control Organization (CDSCO) for both teleproctoring and telesurgery, highlighting its compliance with safety and efficacy standards [6].

Core Insights - SS Innovations International, Inc. has installed over 100 SSi Mantra surgical robotic systems across India and six other countries, with more than 5,000 surgical procedures performed to date, including 240 cardiac surgeries and 32 telesurgeries [1][2] - The company aims to democratize access to robotic surgery and plans to submit a De Novo application to the U.S. FDA for marketing approval of the SSi Mantra by the end of July 2025, while also pursuing CE marking certification in the European Union by late 2025 [2] Company Overview - SS Innovations develops innovative surgical robotic technologies with a focus on affordability and accessibility for a larger segment of the global population, featuring the SSi Mantra surgical robotic system and the SSi Mudra surgical instruments [3] - The company is headquartered in India and aims to expand its global presence with user-friendly and cost-effective surgical robotic solutions [3] Product Details - The SSi Mantra surgical robotic system is a modular, multi-arm system equipped with advanced technology features, including 3 to 5 robotic arms, a 3D 4K monitor, and the ability to superimpose 3D diagnostic imaging models [4] - It has been clinically validated in over 100 different types of surgical procedures, supporting various specialties, including cardiac surgery [4]

Core Insights - SS Innovations International, Inc. has successfully completed the world's first robotic telesurgery for weight loss using the SSi Mantra 3 surgical robotic system, marking a significant milestone in the field of robotic surgery [2][3][5] Company Overview - SS Innovations is dedicated to making robotic surgery affordable and accessible globally, with a focus on innovative surgical robotic technologies [2][7] - The company is headquartered in India and aims to expand its global presence with user-friendly and cost-effective surgical robotic solutions [7] Surgical Procedure Details - The telesurgery involved two One-Anastomosis Gastric Bypass (OAGB) surgeries, which are advanced bariatric procedures aimed at long-term weight loss and improved metabolic health [4][8] - The surgeries were performed remotely over a distance of 560 miles, showcasing the capabilities of the SSi Mantra 3 system with zero perceptible lag and flawless precision [3][8] Technological Advancements - The SSi Mantra surgical robotic system features a modular design with 3 to 5 robotic arms, an ergonomic command center, and advanced imaging capabilities, supporting various surgical specialties [11] - The system has been clinically validated in over 100 different types of surgical procedures in India, demonstrating its versatility and effectiveness [11] Vision and Impact - The company emphasizes its mission to democratize robotic surgery, bridging healthcare gaps and making advanced surgical care accessible to remote regions [5][6] - SS Innovations aims to redefine surgical care access, equity, and excellence through its innovative technologies and humanitarian vision [6]

Core Insights - SS Innovations International, Inc. has successfully completed the world's first robotic telesurgery for weight loss using the SSi Mantra 3 surgical robotic system, marking a significant advancement in robotic surgery technology [1][4] Company Overview - SS Innovations is dedicated to making robotic surgery affordable and accessible globally, with a focus on innovative surgical robotic technologies [5] - The company is headquartered in India and aims to expand its global presence with user-friendly and cost-effective surgical robotic solutions [5] Technological Achievement - The robotic telesurgery bridged a distance of 560 miles between Gurugram and Indore, India, performed with zero perceptible lag and flawless precision [2][7] - The procedures involved two One-Anastomosis Gastric Bypass (OAGB) surgeries, showcasing the capabilities of the SSi Mantra 3 system [3][7] Leadership Commentary - Dr. Sudhir Srivastava, CEO, emphasized that this achievement bridges healthcare gaps and makes advanced surgical expertise accessible to remote regions [4] - Dr. Mohit Bhandari, who led the surgery, highlighted the potential of robotic telesurgery to redefine surgical care and improve access to healthcare [4] Future Vision - SS Innovations aims to continue refining its technology to enhance surgical efficiency and improve patient outcomes, particularly in underserved areas [4]

[Financial and Operational Highlights](index=1&type=section&id=Financial%20and%20Operational%20Highlights) This section summarizes SS Innovations' strong financial performance in Q1 2025 and outlines key business and strategic advancements [First Quarter 2025 Overview](index=1&type=section&id=First%20Quarter%202025%20Overview) SS Innovations reported record quarterly revenue of $5.1 million for Q1 2025, a 40.8% increase year-over-year, driven by higher sales of its SSi Mantra 3 surgical robotic system Q1 2025 Financial Highlights (vs. Q1 2024) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $5.1 million | $3.6 million | +40.8% | | Gross Profit | $1.1 million | $0.7 million | +49.3% | | Gross Margin | 21.23% | 20.02% | +121 bps | | Net Loss | $(5.7) million | $(9.8) million | Narrowed | | Net Loss per Share | $(0.03) | $(0.06) | Narrowed | | SSi Mantra Installations | 15 units | 9 units | +66.7% | Q1 2025 Revenue Breakdown and Operational Metrics (vs. Q1 2024) | Category | Q1 2025 | Q1 2024 | % Change | | :--- | :--- | :--- | :--- | | System sales | $4,502,482 | $3,494,759 | +28.8% | | Instrument sales | $477,208 | $118,515 | +302.7% | | Warranty sales | $122,504 | $9,407 | +1,202.3% | | **Total revenue** | **$5,120,610** | **$3,637,693** | **+40.8%** | | SSi Mantra installations | 15 | 9 | +67% | | Cumulative installed base | 78 | 24 | +225% | | SSi Mantra surgeries | 787 | 361 | +118% | | Cumulative surgeries | 3,568 | 981 | +264% | - The company ended the quarter with **$15.9 million** in cash and cash equivalents and zero long-term debt[5](index=5&type=chunk) [Business and Strategic Developments](index=1&type=section&id=Business%20and%20Strategic%20Developments) Following the quarter, the company uplisted its stock to the Nasdaq Capital Market, while focusing on global expansion and key operational milestones - The company is on track to submit a De Novo application for the SSi Mantra 3 system to the U.S. Food and Drug Administration (FDA) by the end of July 2025[1](index=1&type=chunk)[6](index=6&type=chunk) - SS Innovations is pursuing a European Union CE Mark decision, with a target of late 2025[6](index=6&type=chunk) - Subsequent to the quarter end, on April 25, 2025, the company's common stock was uplisted to The Nasdaq Capital Market®[3](index=3&type=chunk) - Key Q1 achievements include: - The SSi Mantra 3 system enabled the world's first robotic cardiac telesurgery - The company debuted a state-of-the-art mobile telesurgery unit in India - Received medical device regulatory approvals in the Philippines and Ukraine[9](index=9&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) This section presents the condensed consolidated balance sheets, statements of operations, and cash flows for SS Innovations, highlighting key financial positions and performance metrics [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets grew to $63.5 million from $42.4 million at year-end 2024, largely due to a significant increase in cash and inventory Balance Sheet Summary | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $15,873,217 | $466,500 | | Total Current Assets | $47,619,943 | $27,416,291 | | **Total Assets** | **$63,456,961** | **$42,385,213** | | Total Current Liabilities | $14,996,713 | $21,330,222 | | **Total Liabilities** | **$22,902,671** | **$28,928,110** | | **Total Stockholders' Equity** | **$40,554,290** | **$13,457,103** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended March 31, 2025, revenues increased 40.8% to $5.1 million, with a significant reduction in stock compensation expense leading to a narrowed net loss of $5.7 million Statement of Operations Summary (Three Months Ended) | Account | March 31, 2025 | March 31, 2024 | | :--- | :--- | :--- | | Total Revenue | $5,120,610 | $3,637,693 | | Gross Profit | $1,087,208 | $728,182 | | Total Operating Expenses | $7,009,061 | $10,560,501 | | Loss from Operations | $(5,921,853) | $(9,832,319) | | **Net Loss** | **$(5,681,353)** | **$(9,841,753)** | | Net Loss Per Share (basic and diluted) | $(0.03) | $(0.06) | - Stock compensation expense decreased significantly to **$2.4 million** in Q1 2025 from **$7.1 million** in Q1 2024, which was a primary driver for the reduction in net loss[15](index=15&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) In Q1 2025, the company used $6.1 million in cash from operating activities, offset by $22.4 million provided by financing activities, resulting in a net increase in cash of $15.4 million Cash Flow Summary (Three Months Ended) | Activity | March 31, 2025 | March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(6,103,374) | $(2,671,918) | | Net cash used in investing activities | $(872,804) | $(127,255) | | Net cash provided by financing activities | $22,406,019 | $2,638,259 | | **Net change in cash** | **$15,429,841** | **$(160,914)** | | Cash and cash equivalents at end of period | $22,078,788 | $6,895,580 | - Financing activities were primarily driven by **$28 million** in proceeds from the issuance of convertible notes to a principal shareholder[17](index=17&type=chunk) - As a supplemental disclosure, **$30.6 million** of convertible notes, including interest, were converted into common stock during the period[17](index=17&type=chunk) [Company and Product Overview](index=2&type=section&id=Company%20and%20Product%20Overview) This section provides an overview of SS Innovations International, Inc., its mission to democratize robotic surgery, and details its flagship SSi Mantra surgical robotic system [About SS Innovations](index=2&type=section&id=About%20SS%20Innovations) SS Innovations International, Inc. is an American company, headquartered in India, that develops surgical robotic technologies with a mission to make robotic surgery affordable and accessible globally - The company's vision is to democratize robotic surgery by making it affordable and accessible to a larger segment of the global population[8](index=8&type=chunk) - The product portfolio includes the SSi Mantra surgical robotic system and SSi Mudra surgical instruments, which support various procedures including robotic cardiac surgery[8](index=8&type=chunk) [About the SSi Mantra](index=3&type=section&id=About%20the%20SSi%20Mantra) The SSi Mantra is a modular, multi-arm surgical robotic system designed for user-friendliness, featuring advanced technologies and clinical validation across over 100 surgical procedures in India - The system is modular with 3 to 5 robotic arms and features an open-faced ergonomic surgeon command center with a large 3D 4K monitor[10](index=10&type=chunk) - It utilizes over 40 different types of robotic endo-surgical instruments to support specialties including cardiac surgery[10](index=10&type=chunk) - The SSi Mantra has been clinically validated in India in more than 100 different types of surgical procedures[10](index=10&type=chunk)

[PART I – FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This section presents the company's financial statements, management's analysis, market risk disclosures, and controls and procedures [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) For Q1 2025, total assets increased to $63.5 million, liabilities decreased to $22.9 million, and net loss improved to $5.7 million, though going concern doubts persist Condensed Consolidated Balance Sheet Data (Unaudited) | Balance Sheet Items | March 31, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $15,873,217 | $466,500 | | Total Current Assets | $47,619,943 | $27,416,291 | | Total Assets | $63,456,961 | $42,385,213 | | **Liabilities & Equity** | | | | Total Current Liabilities | $14,996,713 | $21,330,222 | | Total Liabilities | $22,902,671 | $28,928,110 | | Total stockholders' equity | $40,554,290 | $13,457,103 | Condensed Consolidated Statements of Operations (Unaudited) | Income Statement Items | Three months ended March 31, 2025 ($) | Three months ended March 31, 2024 ($) | | :--- | :--- | :--- | | Total revenue | $5,120,610 | $3,637,693 | | Gross Profit | $1,087,208 | $728,182 | | Loss from operations | ($5,921,853) | ($9,832,319) | | Net Loss | ($5,681,353) | ($9,841,753) | | Net loss per share - basic and diluted | ($0.03) | ($0.06) | Condensed Consolidated Statements of Cash Flows (Unaudited) | Cash Flow Items | Three months ended March 31, 2025 ($) | Three months ended March 31, 2024 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | ($6,103,374) | ($2,671,918) | | Net cash used in investing activities | ($872,804) | ($127,255) | | Net cash provided by financing activities | $22,406,019 | $2,638,259 | | Net change in cash | $15,429,841 | ($160,914) | - The company's reliance on related parties for funding and a history of net losses raise substantial doubt about its ability to continue as a going concern, necessitating further funding for operations[26](index=26&type=chunk)[36](index=36&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=34&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management reports a 40.8% revenue increase and reduced net loss in Q1 2025, driven by higher sales and lower stock compensation, despite ongoing going concern doubts [Results of Operations](index=34&type=section&id=Results%20of%20Operations) For Q1 2025, total revenue increased to $5.1 million, gross profit rose to $1.1 million, and net loss decreased to $5.7 million due to reduced stock compensation expenses Comparison of Operations for the three months ended March 31 | Metric | 2025 ($) | 2024 ($) | | :--- | :--- | :--- | | Total Revenue | $5,120,610 | $3,637,693 | | Gross profit | $1,087,208 | $728,182 | | Research & development expense | $1,010,095 | $527,991 | | Stock compensation expense | $2,379,212 | $7,108,750 | | Selling, general and administrative expense | $3,410,872 | $2,843,659 | | Loss from operations | ($5,921,853) | ($9,832,319) | | Net loss | ($5,681,353) | ($9,841,753) | - Revenue increased primarily due to the sale of an increased number of surgical robotic systems and instruments in Q1 2025 compared to Q1 2024[181](index=181&type=chunk) - The significant decrease in net loss was primarily the result of a **$4.7 million reduction** in stock compensation expense, partially offset by a **$0.57 million increase** in SG&A expenses[189](index=189&type=chunk) - Research and development expenses nearly doubled to **$1.01 million**, reflecting the company's continued focus on improving its SSi Mantra surgical robotic system[183](index=183&type=chunk) [Liquidity and Capital Resources](index=36&type=section&id=Liquidity%20and%20Capital%20Resources) The company's Q1 2025 liquidity significantly improved due to $22.4 million in financing activities, primarily from a $28 million convertible note issuance, despite ongoing going concern doubts - In January 2025, the company raised **$28 million** from an affiliate through a 7% convertible promissory note, with **$30 million** in principal plus accrued interest subsequently converted into common stock in February and March 2025[196](index=196&type=chunk)[198](index=198&type=chunk)[199](index=199&type=chunk) Cash Flow Summary for the three months ended March 31, 2025 | Cash Flow Activity | Amount ($) | | :--- | :--- | | Net cash used in operating activities | ($6,103,374) | | Net cash used in investing activities | ($872,804) | | Net cash provided by financing activities | $22,406,019 | | **Cash at the end of period** | **$22,078,788** | - Despite recent fundraising, management states there are no committed sources of funding, raising substantial doubt about the Company's ability to continue as a going concern[207](index=207&type=chunk) [Critical Accounting Policies](index=37&type=section&id=Critical%20Accounting%20Policies) Critical accounting policies involve significant management judgment, particularly in valuing stock options and determining standalone selling prices for bundled revenue contracts - Critical accounting policies involve significant estimates, including the fair value of stock options and the standalone selling price in bundled revenue contracts[209](index=209&type=chunk) - The fair value of stock-based awards is determined at the grant date using models like Black-Scholes, which requires significant judgment on inputs like expected volatility and term[210](index=210&type=chunk)[211](index=211&type=chunk) - For sales with multiple products and services, revenue is allocated based on relative standalone selling prices, estimated using market conditions and historical data if not directly observable[214](index=214&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) This section is not applicable for the reporting period - Not applicable[217](index=217&type=chunk) [Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) As of March 31, 2025, the company's disclosure controls were ineffective due to material weaknesses, prompting a remediation plan including enhanced reviews and a new ERP system - Management concluded that the company's disclosure controls and procedures were **not effective** as of March 31, 2025[220](index=220&type=chunk) - Material weaknesses identified include: failure to properly apply U.S. GAAP, lack of written documentation of internal control policies, and insufficient segregation of duties within accounting functions[220](index=220&type=chunk) - The remediation plan includes enhancing transaction review processes, engaging external experts for guidance, and implementing a new comprehensive cloud-based ERP system[221](index=221&type=chunk)[222](index=222&type=chunk) [PART II - OTHER INFORMATION](index=41&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, unregistered equity sales, defaults, mine safety, other information, and exhibits [Legal Proceedings](index=41&type=section&id=Item%201.%20Legal%20Proceedings) The company is involved in litigation in the Bahamas regarding a disputed 9% ownership claim in its subsidiary, Otto Pvt Ltd, with the CEO providing full indemnification - In April 2024, an ex-shareholder of the subsidiary Otto Pvt Ltd initiated litigation in the Bahamas, claiming ownership of **9,000 shares** (approx. **9% interest**)[226](index=226&type=chunk) - The company asserts the shareholding was cancelled in July 2022 due to the plaintiff's failure to pay the agreed-upon consideration, and the company believes the outcome will be favorable[226](index=226&type=chunk) - The company's CEO, Dr. Sudhir Srivastava, has entered into an Indemnification Agreement to fully cover any claims, damages, and legal fees the company may incur from this litigation[227](index=227&type=chunk) [Risk Factors](index=41&type=section&id=Item%201A.%20Risk%20Factors.) This section is not applicable for the reporting period - Not Applicable[229](index=229&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=41&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) Between December 2024 and March 2025, the company received **$30 million** in financing from its CEO's holding company via convertible notes, which were subsequently converted into **21,858,368 shares** of common stock at **$1.38 per share** - The company received **$30 million** in financing from its CEO's holding company, Sushruta Pvt Ltd, through several tranches of one-year 7% convertible promissory notes issued between December 2024 and March 2025[230](index=230&type=chunk) - As of March 31, 2025, the entire **$30 million principal** plus **$164,548 in interest** was converted into **21,858,368 shares** of common stock at a conversion price of **$1.38 per share**[230](index=230&type=chunk) - The securities were issued in reliance on the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933[231](index=231&type=chunk) [Defaults Upon Senior Securities](index=41&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) None reported - None[232](index=232&type=chunk) [Mine Safety Disclosures](index=41&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This section is not applicable - Not applicable[233](index=233&type=chunk) [Other Information](index=41&type=section&id=Item%205.%20Other%20Information.) None reported - None[233](index=233&type=chunk) [Exhibits](index=42&type=section&id=Item%206.%20Exhibits) The report includes Section 302 and Section 906 certifications from the CEO and CFO, along with Inline XBRL financial data files - Filed exhibits include Section 302 and 906 certifications from the CEO and CFO[234](index=234&type=chunk) - Inline XBRL documents (Instance, Schema, Calculation, Definition, Label, and Presentation) are also included as exhibits[234](index=234&type=chunk)

Core Viewpoint - SS Innovations International, Inc. is focused on making robotic surgery affordable and accessible globally, and it has reiterated its guidance for the first quarter of 2025, indicating a positive growth trajectory following its uplisting to Nasdaq [1][2]. Company Updates - The company anticipates reporting its first quarter 2025 financial results around May 15, 2025 [2]. - As of March 31, 2025, a total of 78 SSi Mantra surgical robotic systems have been installed, with 14 systems installed during the first quarter of 2025 [6]. - Revenue for the first quarter of 2025 is expected to be approximately $6.4 million, with a gross margin of around 45% based on preliminary unaudited results [6]. - By April 30, 2025, 80 SSi Mantra robotic surgical systems were installed in 75 hospitals, and over 3,800 surgeries have utilized the SSi Mantra, including more than 200 robotic cardiac surgeries [6]. - In April 2025, the company received 9 orders for the SSi Mantra robotic surgical system, representing a 200% increase from 3 orders in April 2024 [6]. Product Information - The SSi Mantra Surgical Robotic System features a modular design with 3 to 5 robotic arms, an ergonomic surgeon command center, a large 3D 4K monitor, and a virtual real-time image display [4]. - The system supports various surgical specialties, including cardiac surgery, and has been clinically validated in over 100 different types of surgical procedures in India [4].

Core Viewpoint - SS Innovations International, Inc. has received approval for its common stock to be listed on The Nasdaq Capital Market, with trading expected to commence on April 25, 2025, under the ticker symbol "SSII" [1][2] Company Overview - SS Innovations is focused on developing innovative surgical robotic technologies aimed at making robotic surgery affordable and accessible globally [4] - The company is headquartered in India and plans to expand its global presence with advanced, user-friendly, and cost-effective surgical robotic solutions [4] Product Information - The SSi Mantra Surgical Robotic System is a modular, multi-arm system featuring advanced technology such as 3 to 5 robotic arms, a 3D 4K monitor, and over 40 types of robotic endo-surgical instruments [5] - The SSi Mantra has been clinically validated in over 100 different types of surgical procedures in India [5] Recent Achievements - The company has installed 80 SSi Mantra systems in 75 hospitals across India and other countries, performing over 3,500 surgeries, including 195 robotic cardiac surgeries with no reported device-related complications [7] - SS Innovations is the first company in India to receive regulatory approval for telesurgery and tele-proctoring procedures, having conducted 16 telesurgeries, including the world's first robotic cardiac telesurgeries over distances up to 1,200 miles [7] - For the year ended December 31, 2024, the company reported revenue of $20.6 million, a 251% increase from $5.9 million in 2023, with a gross margin of 40.9%, up from 12.3% in 2023 [7][8] Strategic Expansion - The uplisting to Nasdaq coincides with the company's global expansion plans into countries such as Nepal, Ecuador, Guatemala, the Philippines, Indonesia, Sri Lanka, and Ukraine, as well as strategic entry into Europe and the United States [3] - The company is pursuing EU CE Mark and U.S. FDA approval for the SSi Mantra surgical robotic system, anticipated in late 2025 and early 2026, respectively [3]

Part I [Business](index=6&type=section&id=Item%201.%20Business) SS Innovations is a commercial-stage surgical robotics company focused on democratizing advanced surgical robotics, particularly in underserved markets - The company is a commercial-stage surgical robotics firm focused on making advanced surgical robotics affordable and accessible, primarily with its **SSi Mantra system**[23](index=23&type=chunk)[24](index=24&type=chunk) - As of December 31, 2024, the company has installed **62 SSi Mantra systems** (58 in India, 4 overseas) and completed over **3,500 surgical procedures**[26](index=26&type=chunk)[29](index=29&type=chunk) - The company is actively seeking regulatory approval in the United States and the European Union, pursuing the FDA's Investigational Device Exemption (IDE) pathway and discussing CE certification[27](index=27&type=chunk) Surgical Procedures Performed with SSi Mantra (as of Dec 31, 2024) | Type of Surgical Procedure | No. of Procedures | % of total procedures | | :--- | :--- | :--- | | General Surgery | 1,077 | 39% | | Urology | 843 | 31% | | Gynaecology | 391 | 14% | | Cardiac | 151 | 5% | | Colorectal | 156 | 6% | | Gastroenterology | 73 | 3% | | Thoracic | 45 | 2% | | Head and Neck | 19 | 1% | | Plastic/Reconstructive | 4 | - | | **Total** | **2,759** | **100%** | [Products and Technology](index=9&type=section&id=Item%201.%20Business%20-%20Products%20and%20Technology) The SSi Mantra 3 system, with 3D 4K vision and modular arms, is the core product, complemented by 'Mudra' instruments and telesurgery - The SSi Mantra 3 system features a surgeon console with **3D 4K resolution** and up to **10x magnification**, modular robotic arm carts, and a separate vision cart for the surgical team[42](index=42&type=chunk)[43](index=43&type=chunk)[44](index=44&type=chunk) - The company offers over **30 reusable 'Mudra' instruments** with wristed joints and motion scaling technology to enhance precision[48](index=48&type=chunk)[49](index=49&type=chunk) - SSi is the only company with **CDSCO approval for telesurgery** and has successfully performed remote cardiac surgeries over distances up to **2,000 kilometers**[51](index=51&type=chunk) - Products under development include the NADI anastomotic connector, a multi-fire clip applier, a robotic stapler, and mixed reality/AI software tools like SSi Maya and SSi Chitrasa[52](index=52&type=chunk)[53](index=53&type=chunk)[54](index=54&type=chunk)[56](index=56&type=chunk) [Market and Strategy](index=12&type=section&id=Item%201.%20Business%20-%20Market%20and%20Strategy) The company's strategy focuses on penetrating underserved markets like India with its cost-effective SSi Mantra system before expanding globally - The initial strategy is to focus on underserved markets like India, which has a large number of hospitals but very low penetration of robotic surgery, before expanding to the U.S. and Europe[72](index=72&type=chunk) - Marketing efforts target large multi-specialty hospitals and leading surgeons to drive broad adoption and build confidence in the SSi Mantra system[73](index=73&type=chunk)[74](index=74&type=chunk) - The company has established evaluation and training agreements with hospital networks in India and with Johns Hopkins University in the U.S. to facilitate familiarization with its system[76](index=76&type=chunk) [Competition](index=19&type=section&id=Item%201.%20Business%20-%20Competition) SS Innovations competes with traditional surgical methods and established robotic surgery companies possessing greater resources and longer operating histories - The company competes with traditional surgical methods and other medical treatments, as well as other robotic surgery companies[123](index=123&type=chunk) - Major competitors in the robotic surgery space include Intuitive Surgical, Medtronic, Johnson & Johnson, and CMR Surgical, most of whom possess greater financial resources and longer operating histories[124](index=124&type=chunk) [Intellectual Property](index=19&type=section&id=Item%201.%20Business%20-%20Intellectual%20Property) The company protects its technology through a portfolio of patents, trademarks, and copyrights, all of which are internally owned Intellectual Property Portfolio Summary | IP Type | Granted | Pending/Applications | | :--- | :--- | :--- | | Utility Patents | 5 | 65 | | PCT International (WIPO) | 0 | 10 | | Design Patents | 30 | 4 | | Trademarks (India) | 40 | 53 (93 total apps) | | Trademarks (International) | 13 | 18 (31 total apps) | | Copyrights | 2 | 0 | - The company's patents and patent applications are not licensed to or from any third parties[132](index=132&type=chunk) [Government Regulation](index=22&type=section&id=Item%201.%20Business%20-%20Government%20Regulation) The company's products are subject to extensive regulation, holding CDSCO approval in India and pursuing FDA and CE certifications for global market entry - The company has CDSCO approval in India for its products, including a unique approval for telesurgery and tele-proctoring capabilities[139](index=139&type=chunk)[140](index=140&type=chunk) - For U.S. market access, the company is pursuing the FDA's Investigational Device Exemption (IDE) pathway and anticipates starting its U.S. IDE study in Q3 2025[142](index=142&type=chunk) - The company is preparing for EU market entry and expects to submit its CE certification application in the second quarter of 2025[159](index=159&type=chunk) - Current approvals permit marketing in **50 non-FDA/EU countries** without further regulatory hurdles and require only minimal registration in an additional **79 countries**[170](index=170&type=chunk) [Risk Factors](index=28&type=section&id=Item%201A.%20Risk%20Factors) As a "smaller reporting company," SS Innovations is not required to provide specific risk factor disclosures - The company is not required to provide risk factor disclosures as it qualifies as a "smaller reporting company"[177](index=177&type=chunk) [Cybersecurity](index=28&type=section&id=Item%201C.%20Cybersecurity) The company maintains a cybersecurity program overseen by the board to protect sensitive data and ensure compliance with medical device standards - The cybersecurity program is overseen by the Head-Server and Network Administrator, with ultimate oversight from the board of directors[180](index=180&type=chunk)[181](index=181&type=chunk) - A specialized consulting firm has been engaged to ensure product cybersecurity compliance with medical device standards such as HIPPA, FDA regulations, and IEC 62443[182](index=182&type=chunk) - The company has not experienced any cybersecurity incidents that have had a material impact on its business, operations, or financial condition[183](index=183&type=chunk) [Properties](index=28&type=section&id=Item%202.%20Properties) The company's primary property is a leased 70,000 sq. ft. facility in Gurugram, India, serving as its headquarters and manufacturing site - The company's principal property is a leased **70,000 sq. ft.** facility in Gurugram, India, used for headquarters and manufacturing[184](index=184&type=chunk) [Legal Proceedings](index=28&type=section&id=Item%203.%20Legal%20Proceedings) The company is involved in litigation in the Bahamas regarding a disputed 9% interest in an indirect subsidiary, with the CEO providing indemnification - An ex-shareholder of an indirect subsidiary, Otto Pvt Ltd., has initiated litigation in the Bahamas claiming a **9% interest** in Otto from a 2021 transaction[185](index=185&type=chunk) - The company believes the claim is invalid as the plaintiff failed to pay for the shares, leading to the cancellation of the shareholding in 2022[185](index=185&type=chunk) - Dr. Sudhir Srivastava has agreed to fully indemnify the company for all costs and damages related to this litigation[186](index=186&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=29&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades sporadically on the OTC Pink market, with a Nasdaq listing application pending, and no plans for future dividends - The common stock trades sporadically on the OTC Pink market under the symbol "**SSII**". The company has applied for a Nasdaq listing, but approval is not guaranteed[189](index=189&type=chunk) - As of April 14, 2025, there were **193,559,340 shares** of common stock outstanding[8](index=8&type=chunk)[190](index=190&type=chunk) - The company has not paid dividends and does not plan to, intending to retain earnings for business use[191](index=191&type=chunk) Equity Compensation Plan Information | Plan category | Number of securities to be issued upon exercise | Weighted average exercise price | Number of securities remaining available for future issuance | | :--- | :--- | :--- | :--- | | Equity compensation plans approved by security holders | 12,142,838 shares | $3.863 | 7,213,096 shares | | Equity compensation plans not approved by security holders | 0 shares | – | 0 shares | | **Total** | **12,142,838** | **$0** | **7,213,096** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=30&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) In 2024, revenue increased to $20.6 million, but a $19.2 million net loss persisted due to high non-cash stock compensation and operational growth costs [Results of Operations](index=31&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20-%20Results%20of%20Operations) For 2024, revenue increased to $20.65 million, and gross profit grew, but a net loss of $19.15 million was recorded due to rising operating expenses Consolidated Statement of Operations Summary (in USD) | Particulars | 2024 | 2023 | | :--- | :--- | :--- | | Total Revenue | 20,649,528 | 5,875,314 | | Gross profit | 8,452,366 | 725,528 | | Loss from operations | (18,975,962) | (20,273,984) | | Net loss | (19,151,197) | (20,878,292) | - Revenue increased significantly to **$20.65 million** in 2024 from **$5.88 million** in 2023, driven by increased sales of surgical robotic systems and instruments[205](index=205&type=chunk) - Stock compensation expense rose to **$14.34 million** in 2024 from **$9.72 million** in 2023, mainly due to new stock grants and options awarded to employees and executives[207](index=207&type=chunk) - Research and Development expenses increased to **$2.49 million** in 2024 from **$1.06 million** in 2023, aligning with the company's focus on enhancing its SSi Mantra system and expanding its product line[206](index=206&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20-%20Liquidity%20and%20Capital%20Resources) The company had a $6.1 million working capital surplus but faces going concern doubts, relying on external financing to fund operations and expansion - The company has a working capital surplus of **$6.1 million** as of Dec 31, 2024, but faces substantial doubt about its ability to continue as a going concern due to recurring losses[215](index=215&type=chunk)[349](index=349&type=chunk) Summary of Cash Flows (in USD) | Particulars | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | (9,503,030) | (15,361,645) | | Net cash used in investing activities | (661,479) | (453,327) | | Net cash provided by financing activities | 9,425,980 | 22,796,286 | | **Cash at end of year** | **6,623,535** | **7,087,845** | - Cash from financing activities in 2024 totaled **$9.4 million**, sourced from a bank overdraft facility (**$2.0M**), convertible notes to the principal shareholder (**$3.0M**), promissory notes (**$3.0M**), and convertible notes to other investors (**$1.45M**)[219](index=219&type=chunk) [Critical Accounting Estimates](index=34&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20-%20Critical%20Accounting%20Estimates) Key accounting estimates involve determining fair value for stock compensation and estimating Standalone Selling Price for bundled revenue contracts - The company identifies determining the fair value of stock-based compensation as a critical accounting estimate, requiring judgment on inputs like stock volatility and expected term[225](index=225&type=chunk)[226](index=226&type=chunk) - Estimating the Standalone Selling Price (SSP) for different components in bundled sales arrangements is another critical estimate, used to allocate revenue among performance obligations like the system, instruments, and services[224](index=224&type=chunk)[229](index=229&type=chunk) [Controls and Procedures](index=35&type=section&id=Item%209A.%20Controls%20And%20Procedures) Management concluded that disclosure controls were ineffective as of December 31, 2024, due to material weaknesses, and a remediation plan is underway - Management concluded that disclosure controls and procedures were not effective as of December 31, 2024[236](index=236&type=chunk) - Material weaknesses identified include: inadequate controls for applying U.S. GAAP, lack of documented internal control policies, and insufficient segregation of duties[247](index=247&type=chunk) - A remediation plan is underway, involving external experts and the implementation of a new cloud-based ERP system to improve internal controls[241](index=241&type=chunk)[242](index=242&type=chunk) Part III [Directors, Executive Officers, and Corporate Governance](index=37&type=section&id=Item%2010.%20Directors,%20Executive%20Officers,%20and%20Corporate%20Governance) The company's leadership includes eight directors, four independent, with established committees and a Code of Ethics, though some insider filings were late - The board consists of eight members, four of whom (Dr. Annadurai, Dr. Somashekhar, Dr. Moll, and Mr. Adams) are determined to be independent[263](index=263&type=chunk) - The company has established Audit, Compensation, and Nominating and Corporate Governance committees, with Tim Adams serving as the 'audit committee financial expert'[262](index=262&type=chunk)[263](index=263&type=chunk) - Dr. Sudhir Srivastava (Chairman & CEO) and Dr. Vishwajyoti P. Srivastava (President & COO – South Asia) are father and son[260](index=260&type=chunk) - Several Form 4 filings for insiders, including Dr. Sudhir Srivastava, were filed late during the reporting period due to administrative oversights[270](index=270&type=chunk)[276](index=276&type=chunk) [Executive Compensation](index=43&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation in 2024 primarily comprised base salaries and substantial stock-based awards, with Dr. Sudhir Srivastava receiving a **$13.3 million** option award 2024 Executive Compensation Summary | Name and Principal Position | Salary ($) | Option Awards ($) | Total ($) | | :--- | :--- | :--- | :--- | | Sudhir Srivastava, M.D. (Chairman and CEO) | 600,000 | 13,307,213 | 14,196,780 | | Anup Kumar Sethi (CFO) | 177,385 | 0 | 178,251 | | Vishwajyoti P. Srivastava, M.D. (President and COO – South Asia) | 200,000 | 2,883,468 | 3,095,632 | | Barry F. Cohen (COO-Americas) | 180,000 | 2,883,468 | 3,063,468 | - The company has employment agreements with its named executive officers, with base salaries ranging from **$175,000 to $600,000** and terms of three to five years[280](index=280&type=chunk)[281](index=281&type=chunk) - Non-employee directors are compensated with periodic grants of options. For 2024, Dr. S.P. Somashekhar received a stock award of **50,000 restricted shares**, which fully vested[286](index=286&type=chunk)[288](index=288&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=46&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Dr. Sudhir Srivastava is the principal shareholder, beneficially owning 58.94% of common stock and controlling 51% of total voting power Beneficial Ownership of Common Stock | Names of beneficial owners | Number of shares | Percentage of class (%) | | :--- | :--- | :--- | | **Directors and executive officers** | | | | Sudhir Srivastava, M.D. | 117,158,445 | 58.94% | | Dr. Frederic H Moll | 20,335,045 | 10.23% | | All directors and executive officers as a group (eight persons) | 152,026,515 | 76.48% | | **5% or greater shareholders** | | | | Manipal Global Health Services | 14,949,070 | 7.52% | - Dr. Sudhir Srivastava holds controlling voting power through his beneficial ownership of **58.94% of common stock** and **100% of Series A Preferred Shares**, which grant him **51% of the total voting power**[294](index=294&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=47&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence) Significant related-party transactions occurred, primarily with CEO Dr. Sudhir Srivastava and his holding company, involving substantial financing and stock compensation - The company received significant financing from its principal shareholder, Sushruta Pvt. Ltd. (owned by CEO Dr. Sudhir Srivastava), including **$6,000,000 in proceeds** from notes issued during 2024[501](index=501&type=chunk) - Significant non-cash ESOP expenses were recorded for key management personnel, including **$6.4 million** for Dr. Sudhir Srivastava and **$1.3 million** for CFO Anup Sethi in 2024[501](index=501&type=chunk) - As of December 31, 2024, the company had a payable balance of **$6,000,000** for notes issued to Sushruta Pvt. Ltd[502](index=502&type=chunk) [Principal Accounting Fees and Services](index=48&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Total audit fees for 2024 significantly increased to $686,326, covering annual audits, quarterly reviews, and services for restatement and S-1 filing Accountant Fees (in USD) | Fee Category | FY 2024 | FY 2023 | | :--- | :--- | :--- | | Audit Fees | 686,326 | 112,500 | | Audit-Related Fees | - | - | | Tax Fees | - | - | | All Other Fees | - | - | | **Total** | **686,326** | **112,500** | - Audit fees for 2024 included expanded services related to the company's financial restatement and S-1 registration statement filing[299](index=299&type=chunk) - All audit services were pre-approved by the Board of Directors, as the audit committee was only recently constituted[304](index=304&type=chunk)[305](index=305&type=chunk) Part IV [Exhibits and Financial Statement Schedules](index=49&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section includes consolidated financial statements, an auditor's report with a going concern warning, and detailed notes on accounting policies and subsequent events - The independent auditor's report from BDO India LLP expresses substantial doubt about the company's ability to continue as a going concern due to recurring losses and negative cash flows[322](index=322&type=chunk) - The auditor identified the determination of Standalone Selling Price (SSP) for multiple-element revenue arrangements as a Critical Audit Matter, due to the significant management judgment involved[327](index=327&type=chunk)[328](index=328&type=chunk) - Subsequent to year-end, in early 2025, the company raised a total of **$28 million** in convertible notes from its principal shareholder, Sushruta Pvt Ltd., and converted a total of **$30 million** in notes and interest into common stock, significantly improving its equity position[504](index=504&type=chunk) [Consolidated Financial Statements](index=55&type=section&id=Consolidated%20Financial%20Statements) The consolidated financial statements show total assets of $42.4M, total liabilities of $28.9M, and a net loss of $19.2M for FY2024 Consolidated Balance Sheet Data (as of Dec 31, in USD) | | 2024 | 2023 | | :--- | :--- | :--- | | Total Assets | 42,385,213 | 31,515,994 | | Total Liabilities | 28,928,110 | 11,797,916 | | Total Stockholders' Equity | 13,457,103 | 19,718,078 | Consolidated Statement of Operations Data (for the year ended Dec 31, in USD) | | 2024 | 2023 | | :--- | :--- | :--- | | Total Revenue | 20,649,528 | 5,875,314 | | Gross Profit | 8,452,366 | 725,528 | | Loss from Operations | (18,975,962) | (20,273,984) | | Net Loss | (19,151,197) | (20,878,292) | | Net loss per share | (0.11) | (0.14) | [Note 5 – Reverse Recapitalization](index=70&type=section&id=Note%205%20%E2%80%93%20REVERSE%20RECAPITALIZATION) The April 14, 2023, transaction with CardioVentures was accounted for as a reverse recapitalization, with CardioVentures as the accounting acquirer - The April 14, 2023 transaction with CardioVentures was accounted for as a reverse recapitalization, with CardioVentures as the accounting acquirer[416](index=416&type=chunk) - Post-merger, former CardioVentures shareholders held **~95% of the common stock** and controlled the company via new Series A Preferred Stock, which carries **51% of the total voting power**[416](index=416&type=chunk)[417](index=417&type=chunk) [Note 20 – Stock Compensation Expenses](index=83&type=section&id=Note%2020%20%E2%80%93%20STOCK%20COMPENSATION%20EXPENSES) Stock compensation expense increased to $14.3 million in 2024, with $25.1 million in unrecognized expense remaining as of year-end Stock Compensation Expense (in USD) | Category | 2024 | 2023 | | :--- | :--- | :--- | | Stock options | 7,546,149 | 3,152,066 | | Restricted stock units (RSU) | 5,479,441 | 6,095,401 | | Advisory shares | 1,317,194 | 476,025 | | **Total** | **14,342,784** | **9,723,492** | - As of Dec 31, 2024, **$25.1 million** of total unrecognized compensation expense remains, to be recognized over a weighted-average period of **2.91 years**[500](index=500&type=chunk) [Note 23 – Subsequent Events](index=87&type=section&id=Note%2023%20%E2%80%93%20SUBSEQUENT%20EVENTS) In early 2025, the company engaged in significant financing, raising $28 million in convertible notes and converting $30 million in notes into common shares - In January and March 2025, the company raised a total of **$28 million** by issuing convertible promissory notes to its principal shareholder, Sushruta Pvt Ltd[504](index=504&type=chunk) - In February and March 2025, the company converted a total of **$30 million** in principal from convertible notes held by Sushruta Pvt Ltd., plus accrued interest, into **21,858,368 common shares**[504](index=504&type=chunk) - In February 2025, the company repaid promissory notes totaling approximately **$5.2 million** to Sushruta Pvt Ltd. and another investor[504](index=504&type=chunk)